Tag Archive for: Audit

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Too many audits, too little effect? Solving audit fatigue in the GMP environment

The increasing number of audits in the GMP environment has long been more than just an organizational issue. For many companies, audit fatigue is developing into a structural problem in the quality system, with direct effects on efficiency, focus and ultimately also on product quality. The solution to this lies in the strategic management of audits, particularly in conjunction with audits by third parties.

Fatigue

What is audit fatigue – and why is it a risk?

Audit fatigue describes the situation in which companies are exposed to an excessive number of audits. This is particularly common in the GMP environment:

  • Contract manufacturers (CMOs)
  • Active ingredient suppliers
  • Global supply chains

It is typical that:

  • several customers carry out almost identical audits
  • similar requirements are checked several times
  • internal departments are strongly bound

However, the real problem is not just the effort involved. As audit density increases, the way a company works often changes too: The focus shifts from sustainable quality improvement to pure audit fulfillment.

From control instrument to management tool: the actual role of audits

An often overlooked aspect in the context of audit fatigue is the question of what function audits should actually fulfill in the quality system. In many organizations, they have historically established themselves as a control instrument that primarily serves to provide external assurance – vis-à-vis authorities, customers or partners. However, this creates a system in which audits function primarily as a verification logic, not as a control instrument.

The more this control logic dominates, the more the focus shifts away from actual quality improvement towards the formal fulfillment of requirements. Audits are then no longer used to identify risks at an early stage or to improve processes in a targeted manner, but rather to meet the expectations of different stakeholders individually. This is precisely where structural inefficiency arises: the same issues are audited multiple times without the findings being systematically combined or strategically used.

A modern audit approach must therefore answer the question of what specific contribution an audit makes more than before. Not every audit automatically increases the quality of the system. On the contrary, an unconnected audit landscape can lead to relevant information being available but not being transferred to a higher-level control logic. The real added value only arises when audits are not viewed in isolation, but are understood as part of a continuous learning and control system.

The blind spot: Missing linking of audit data

One aspect that is underestimated in many companies is the lack of integration of audit results into the overall system. Audit reports often exist in isolation alongside CAPA systems, deviation management or supplier evaluation, without being systematically linked together. As a result, key findings are lost: it remains unclear which patterns emerge across several audits, where weaknesses are repeated or which risks are already known but not consistently addressed. Without this linking, even a high audit density remains analytically underutilized and its actual added value for the quality system is limited.

Audits by third parties: More than just relief

Audits by independent third parties are often seen primarily as a means of reducing audit costs. However, their actual potential goes much further.

Used correctly, they can:

  • Establish comparability between suppliers
  • Creating a uniform evaluation logic
  • The following serve as a central database for several clients

This makes it possible to systematically evaluate and aggregate audit results instead of just looking at them individually. The added value lies not only in fewer audits, but also in better, more consistent findings.

Prerequisite: Trust and evaluation logic

For third-party audits to be fully effective, it is not enough for them to be carried out externally. Rather, it is crucial that they are based on a consistent and comprehensible assessment logic. This includes clearly defined criteria, uniform assessment standards and transparent risk classifications that are understandable and comparable for all parties involved. Equally important is structured and complete documentation that makes it possible to trace findings, assessments and conclusions at any time.

Audit reports can only serve as a reliable basis for decision-making if these requirements are met. This is particularly relevant if several clients are to rely on the same audit results. If this trust in methodology and informative value is lacking, external audits are often not accepted – with the result that additional, redundant audits are carried out.

In addition, a clear evaluation logic creates the basis for systematically integrating audit results into existing quality systems, for example in supplier evaluations or risk-based audit planning. Only then do audits by third parties develop their true added value: they not only reduce the effort involved, but also improve the comparability, transparency and controllability of quality throughout the entire system.

From individual audits to audit ecosystems

A forward-looking approach is therefore to no longer view audits as isolated individual activities, but to see them as part of a networked audit ecosystem. Instead of conducting and documenting individual audits independently of each other, internal audits, supplier audits and third-party audits are systematically interlinked and placed in a common context.

The results of these different types of audit are incorporated into central evaluations, creating a more comprehensive picture of the actual quality and risk situation. Individual findings are no longer considered in isolation, but are analyzed and classified in combination. This allows risks to be prioritized across the board instead of evaluating them solely on the basis of individual audit reports.

In such a model, the role of the quality unit also changes fundamentally. It is no longer solely responsible for the planning, implementation and follow-up of individual audits, but increasingly takes on a controlling and evaluating function. The focus is then less on pure audit management and more on the interpretation of data and the derivation and prioritization of measures based on an integrated overall picture.

Risk-based management becomes mandatory

At the same time, the regulatory focus is clearly shifting towards risk-based approaches.

For audit strategies this means:

  • Less rigid cycles
  • More dynamic adjustment based on data
  • Targeted use of third-party audits for stable or standardized suppliers

Audit fatigue often arises precisely where this step has not yet been consistently implemented.

Conclusion on audit fatigue

Audit fatigue is ultimately a symptom of increasing complexity in regulated environments, but it is also a clear signal that existing audit strategies need to be fundamentally developed further. If organizations audit more and more frequently without systematically networking and using the knowledge gained, this creates a growing burden without increasing the actual added value to the same extent.

The central key to the solution lies in the consistent linking of audit data across different sources, clear risk-based management and the targeted and strategic use of audits by third parties. Only when these elements are considered together can a consistent and resilient overall system be created that strengthens both efficiency and effectiveness.

Companies that tackle this change at an early stage benefit in two ways: on the one hand, the operational burden caused by redundant or poorly coordinated audit activities is reduced and, on the other, the basis for decision-making is improved as information is available in a more structured, comparable and meaningful way. The decisive factor here is not a reduction in control, but more structure, better integration and more intelligent use of existing information.

How we support you

If you want to actively reduce audit fatigue and make your audit strategy more efficient, structured and risk-oriented, an external perspective can be crucial. External audits not only create additional objectivity, but also help to critically scrutinize existing audit processes, identify duplicate structures and gain real added value from your quality data. This is exactly where we come in: with independent, practical audits that not only check, but also provide orientation and make concrete optimization potential visible. Get ahead and in touch with us: info@expertsinstitut.de

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Supplier management in the GMP industry: regulatory framework and qualification

Effective supplier management in the GMP sector is more than just an operational purchasing process. In highly regulated environments such as pharmaceuticals, biotechnology or active ingredient manufacturing, the systematic qualification and monitoring of suppliers is crucial for product quality, patient safety and regulatory compliance.

With the increasing global networking of supply chains and growing inspection requirements, the regulatory framework is coming more into focus. Companies must design their supplier management in such a way that it not only functions operationally, but is also resilient and audit-proof from a regulatory perspective.

Supplier management

Why supplier management is regulatory critical under GMP

In the GMP world, one central principle applies: responsibility cannot be delegated. Even if activities are outsourced, the client remains fully responsible for the quality of the end product. Errors or weaknesses on the supplier side can have a direct impact on your own organization. These include delayed batch releases, necessary deviation investigations and CAPA measures, critical inspection findings and, in the worst case, market or supply risks.

Structured and documented supplier management is therefore not a voluntary quality instrument, but an elementary component of a functioning GMP system.

The regulatory framework: EU GMP Chapter 7 at the center

EU GMP Chapter 7 is part of the European GMP guidelines (EudraLex Volume 4) and regulates the handling of outsourced activities. It defines the requirements for companies that outsource processes or services to external partners and makes it clear that responsibility for product quality remains with the client.

The core of the chapter is the requirement for clear, written agreements between the client and contractor as well as structured qualification and ongoing monitoring of the service provider. Companies must ensure that external partners have suitable premises, qualified personnel, appropriate equipment and an effective quality system.

In practice, this means that companies must be able to prove to inspectors that suppliers were qualified before the start of the collaboration, that a sound risk assessment was carried out, that audit programs are planned and implemented on a risk basis and that identified deviations are systematically followed up and closed. Missing or merely superficial supplier assessments regularly count as critical inspection findings and can have significant regulatory consequences.

Annex 16 – Responsibility for batch certification

Annex 16 is a supplementary document to the EU GMP guidelines and deals with the certification of batches by the Qualified Person (QP ). It specifies the requirements for the release of batches of medicinal products and emphasizes the comprehensive responsibility of the QP.

Annex 16 is particularly relevant in the context of supplier management because the qualified person may only certify a batch if they are convinced that all GMP requirements – including those for outsourced activities – have been met. This requires a reliable understanding of the entire supply chain. Quality agreements must be clearly regulated, responsibilities must be clearly assigned and critical process steps at the supplier must be transparently traceable. Supplier management is therefore directly linked to the marketability of a product.

ICH Q9 – Quality Risk Management as a methodological basis

ICH Q9 is an internationally harmonized guideline of the International Council for Harmonization (ICH) and describes the principles of quality risk management in the pharmaceutical environment. The aim is to systematically identify, assess, control and continuously monitor risks to product quality.

In this context, a risk-based approach means that not all suppliers are treated equally, but are managed depending on their criticality and their influence on product quality and patient safety. Factors such as material criticality, influence on batch release, previous performance or regulatory history are included in the assessment. Audit frequencies, monitoring measures and resources are prioritized on this basis.

Documented, traceable quality risk management is a key expectation of authorities today. Companies that manage their suppliers on a risk-based basis not only increase their regulatory robustness, but also the stability of their supply chain.

Interaction of EU GMP Chapter 7, Annex 16 and ICH Q9

EU GMP Chapter 7, Annex 16 and ICH Q9 pursue different but closely linked objectives in supplier management. EU GMP Chapter 7 forms the binding regulatory framework for outsourced activities and defines the organizational and contractual requirements for companies. Annex 16 specifies this responsibility from the perspective of batch certification and focuses on the role of the qualified person – with direct reference to the practical release decision.

ICH Q9, on the other hand, is not a legal requirement, but an internationally harmonized guideline that provides the methodological basis for systematic, risk-based quality management. While Chapter 7 and Annex 16 define what is required by regulation, ICH Q9 describes how risks can be assessed, prioritized and managed in a structured manner. Taken together, they form the legal, operational and methodological framework for resilient and audit-proof supplier management in the GMP environment.

Supplier qualification in practice

GMP-compliant supplier qualification begins before the contract is signed and comprises several stages:

1. pre-qualification

  • Questionnaires
  • Document review (e.g. certificates, audit reports, QMS documentation)
  • Risk classification

2. auditing

  • On-site audits or remote audits
  • Evaluation of system effectiveness
  • Focus on critical process steps

3. contract design

  • Binding quality agreements
  • Clear definition of responsibilities
  • Regulation of deviations and changes

4. continuous monitoring

  • KPI-based evaluation
  • Requalification
  • CAPA tracking

The decisive factor is that the aim is not formal checklist fulfillment, but the evaluation of the actual effectiveness of the quality system.

Audit techniques in the GMP environment: From control instrument to dialog

Modern supplier audits are far more than mere control mechanisms for checking regulatory requirements. They are a strategic tool for creating transparency, building process understanding and strengthening cooperation with critical partners in the long term. An effective audit begins with a clear definition of the scope of the audit and a risk-oriented focus. This involves specifically analyzing which processes are particularly relevant for product quality and patient safety.

During the audit, the focus is not only on identifying deviations, but above all on evaluating the effectiveness of the system. The decisive factor is whether the supplier’s quality system is suitable for identifying risks at an early stage and managing them effectively. Equally important is the structured follow-up of identified deviations. If audit findings are not processed consistently, the audit loses its sustainable benefit.

When used correctly, supplier audits develop from a pure control instrument into a dialog format that promotes mutual understanding and creates the basis for stable, long-term partnerships. Companies that strategically focus their audit programs on critical suppliers (i.e. partners with a direct influence on product quality, patient safety or batch certification) and consistently integrate the results into their own quality management reduce regulatory risks and strengthen their supply chain integrity.

Typical weak points in inspections

In practice, there are frequently recurring defects:

  • Unclear responsibilities in the Quality Agreement
  • Lack of risk-based classification
  • Insufficient audit follow-up
  • Incomplete documentation
  • No systematic requalification

A resilient supplier management system must address these weak points preventively.

Conclusion: Supplier management as a strategic compliance factor

Effective supplier management in accordance with GMP is a regulatory obligation, systematic risk management and strategic stability factor at the same time. EU GMP Chapter 7 and Annex 16 make it clear that responsibility does not end at the company boundary, but continues along the entire supply chain. ICH Q9 provides the methodological framework for fulfilling this responsibility in a risk-based and efficient manner.

Companies that organize supplier management in a structured, documented and risk-oriented manner create the basis for reliable batch certification, stable market supply and long-term compliance. Compliance creates security – cooperation based on partnership creates stability.

How we support you

Experts Institut supports companies in making their supplier management GMP-compliant and audit-proof. We support you in the risk-based evaluation and classification of suppliers in accordance with ICH Q9, review and create quality agreements, conduct supplier audits and provide support in the professional evaluation and implementation of CAPA measures. In addition, we help you to structure your existing quality management system in such a way that regulatory requirements can be met in a comprehensible manner and presented to the authorities in a reliable manner.

If you want to strategically develop your supplier management and combine regulatory security with operational stability, we will be happy to assist you. Get ahead and in touch with us: info@expertsinstitut.de

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Mastering GMP audits successfully: What really matters

GMP audits are one of the key quality assurance tools in the pharmaceutical and life science industry. They check whether manufacturing processes, documentation, systems and working methods comply with regulatory requirements at all times. This is not just about compliance with formal requirements, but also about ensuring product safety, process stability and quality in practice. Successful GMP audits therefore make a significant contribution to patient safety, corporate risk minimization and a sustainable compliance culture.

GMP audits

Why GMP audits are of strategic importance

An audit is much more than just an inspection. It signals quality, transparency and a sense of responsibility towards customers, authorities and patients. Companies that establish audit stability as part of their organizational culture not only benefit from regulatory security, but also from better internal processes, clear responsibilities and increased efficiency. Findings are not a failure, but a valuable indicator for further development.

Audit preparation

Preparation for a GMP audit does not just begin in the days leading up to the date, but is part of continuous compliance management. An audit-compliant company is characterized by complete and up-to-date documentation, clear responsibilities, uniform standards and structured training and competence management. Internal communication is also an important building block: employees should understand why audits take place, what expectations exist and how they can communicate in a secure and fact-based manner. Many companies use internal mock audits or Q&A training to create security and practice typical situations in a realistic manner.

Audit implementation

During the audit, the focus is on clarity, traceability and integrity. Auditors not only evaluate documents and processes, but also the organization as a whole: Do employees know how processes work? Can decisions be explained? Is there a visible quality culture? Successful audit participants answer precisely, based on facts and only within their area of responsibility. Equally important is structured on-site support for the audit: a defined process, prepared rooms, clean accompanying documentation and professional communication support a positive result.

Follow-up

The phase after the audit determines the long-term benefit. Findings should be analyzed systematically and not viewed in isolation. Root cause analyses help to identify structural weaknesses instead of merely remedying symptoms. Action plans should be realistically scheduled, have clear responsibilities and then be checked for their effectiveness. This creates a learning system that continuously optimizes quality.

Typical audit risks and how companies can prevent them

In many GMP-regulated organizations, audit deviations are not caused by a lack of expertise, but by process gaps, inconsistent implementation and poor documentation quality. Common risk factors are:

– Incomplete, contradictory or outdated documents
– Process knowledge that only exists verbally (“tribal knowledge”)
– Lack of justification or risk considerations in decisions
– Training certificates without verifiable competence assessment
– Poor data integrity or unclear roles and responsibilities

An effective approach therefore does not lie in short-term “polishing up” before an audit, but in operational routine quality: processes must be designed in such a way that they are auditable at all times and are transparent, reproducible, risk-based and compliant with data integrity. Audit stability is achieved when documents reflect reality and reality is lived in accordance with the rules.

Support from the Experts Institute

We support companies in all audit phases, from the initial assessment to the implementation of practical mock audits and the sustainable implementation of corrections. Our work is practice-oriented, based on regulatory requirements and geared towards the individual level of maturity. In doing so, we pursue the goal of permanently anchoring audit stability and making quality tangible, comprehensible and measurable.

Conclusion: Audit strength comes from practiced quality

Successful GMP audits are no coincidence, but the result of a professional quality culture, clear responsibilities and continuous improvement. Companies that see audits as an opportunity rather than a burden strengthen their competitiveness, increase their compliance level and promote sustainable, process-oriented corporate development.

If you would like to increase your audit stability or develop your processes to the next level of maturity, we will be happy to support you. Get ahead and in touch with us – info@expertsinstitut.de

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GxP audits: How important are they and how are they conducted?

In the highly regulated pharmaceutical industry, audits are more than just a control mechanism – they are an indispensable tool for ensuring the quality and compliance of processes. Audits play a key role in ensuring that companies adhere to the strict requirements of Good Manufacturing Practice (GMP) and other GxP standards. The aim is not only to identify errors, but also to continuously improve processes and eliminate weaknesses before they lead to errors or quality problems. The role of audits in quality management can therefore not be overestimated. They help to meet regulatory requirements and at the same time strengthen the trust of customers and authorities in the company.

Below you will find out what a GxP audit is, why it is so important for companies in regulated industries and how it can be carried out optimally.

What is a GxP audit?

An audit is a systematic, independent and documented review that serves to determine whether activities and results meet the planned requirements. So much for the theory.

In the GxP area, audits are particularly important in practice, as they ensure that all processes actually meet the strict requirements of GMP, GLP and GCP standards. These audits not only check compliance with regulations, but also whether processes are used for continuous improvement and risk reduction and actually make this contribution.

Why are audits in the GxP area so important?

Audits fulfill a central function in the so-called Pharmaceutical Quality System (PQS) and offer many advantages that are important for the entire industry:

  • Audits guarantee that companies comply with and implement the legal and regulatory requirements in such a way that the medicines produced are of truly impeccable quality and also safe.
  • Audits make it possible to identify potential errors in operations and production at an early stage so that measures can be taken to minimize risks. This prevents critical errors or weaknesses in the production process from leading to serious problems and questionable medicines from reaching the market and patients.
  • Audits offer the opportunity to evaluate existing processes and identify optimization potential. In this way, companies can increase their efficiency and improve quality at the same time.
  • Regular audits strengthen the trust of customers, partners and regulatory authorities. A well-documented and executed audit shows that the company is able to critically scrutinize itself in order to reliably deliver high-quality products to the market.

The audit process: step by step

An audit in the GxP area follows a structured procedure that enables the auditor to thoroughly examine the processes in the company. Typically, an audit consists of six main phases:

  1. Planning: Audit preparation is crucial for success. The parties involved must ensure that all relevant people and documents are available. Thorough planning ensures a smooth process.
  2. The initial meeting: In this step, the auditors and the representatives of the company to be audited meet at the start of the audit. The audit plan or the audit agenda is discussed again. Questions are also clarified here and expectations are defined if they have not already been clearly understood before the audit.
  3. Conducting the audit: The auditor checks the company’s premises, machines, documents and processes. Interviews with employees also take place during this phase in order to assess the practical implementation of the processes.
  4. The final meeting: At the end of the audit, the results are summarized. This is where we discuss what worked well and where there is room for improvement.
  5. The audit report: The auditor prepares a detailed report documenting the results of the audit. This report also contains recommendations to help the company eliminate weaknesses and further improve processes.
  6. Follow-up of the audit results: After the audit, follow-up is essential to ensure that the recommended measures have been implemented. This includes documenting the corrections and, if necessary, rechecks to ensure the sustainability of the improvements.

Preparing the audited company for a GxP audit: how to succeed

Thorough preparation is the key to a successful audit. Companies should ensure that their documents are complete and up-to-date and that their employees are aware of the requirements of the audit. Employee training plays a central role here, as a well-prepared team helps to ensure that the audit runs smoothly and possible deficiencies can be identified at an early stage.

Tips for audit preparation:

  • Review all important documents, including SOPs (standard operating procedures), batch documentation and qualification documents
  • If possible, carry out internal mock audits in advance to identify weaknesses in advance
  • Bring your team up to speed on regulatory requirements and audit expectations

Successful audit practice: the key to success

A successful audit requires careful preparation, a clear structure and detailed follow-up. Cooperation between the auditor and the audited company is of great importance in order to develop a common understanding of the requirements and expectations. This not only promotes compliance, but also the continuous improvement of processes. Companies that integrate regular audits into their business processes improve their quality assurance and reduce the risk of production errors or non-compliance with regulations.

Conclusion: Audits as the key to quality assurance

Audits are an indispensable part of quality management in the GxP sector. They not only help to ensure compliance with regulations, but also promote the quality and safety of products. Thorough preparation and the selection of experienced auditors are crucial to the success of an audit.

At Experts Institut, we not only offer training courses for auditors, but are also happy to support you in ensuring your compliance and continuously improving your processes. We can do “audits”. Contact us at info@expertsinstitut.de

Would you like to find out more?

Listen to our podcast episode “Audits in the pharmaceutical industry”, in which we examine the importance and challenges of audits in detail: https://podcasters.spotify.com/pod/show/experts-insights/episodes/Audits-in-der-Pharmaindustrie-e2of577

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ISO 9001 certification: Step by step to a successful QMS

ISO 9001 certification is an internationally recognized standard in quality management. It stands for trust, efficiency and reliability – qualities that customers and business partners value. However, the certification process can seem challenging. In this guide, you will learn how to successfully implement certification and how we can support you step by step.

Why ISO 9001 certification?

ISO 9001 certification offers many advantages: more efficient processes, better risk management and greater trust from customers and partners. It can also open up new business opportunities, as many tenders and contracts require ISO certification.

ISO 9001

1. initial consultation and analysis: the start

The first step towards ISO 9001 certification is a comprehensive analysis of your existing structures and processes. This will determine how well your quality management system (QMS) already meets the requirements of the standard and where improvements are needed.

Why is this important? Many companies already unconsciously fulfill parts of the ISO 9001 standards. A professional analysis uncovers these strengths and identifies specific weaknesses in order to make the process efficient and time-saving.

2. planning the implementation: tailored to your requirements

Following the analysis, a customized implementation plan is drawn up that defines all the steps required for full compliance with ISO 9001 standards.

What makes this step so important? Thoughtful planning ensures that the standard requirements are implemented without disrupting your day-to-day operations. This maximizes the benefits of certification and minimizes disruption.

3. implementation of the quality management system (QMS)

Now it is a matter of either implementing the QMS from scratch or optimizing existing processes. This ensures that all requirements of the ISO 9001 standard are met.

Why is this important? An optimized QMS not only improves the quality of your products and services, but also increases efficiency. Clear processes, reduced errors and motivated employees contribute to successful certification.

4. internal audits and training: Preparation is everything

Internal audits and the training of your employees are essential components before the official certification audit begins. They identify weak points and ensure that the QMS is implemented correctly. At the same time, employees are prepared for the new processes.

Why this step? Training ensures that employees understand the new processes and use the QMS efficiently. The internal audits ensure that your company is ready for official certification.

5th certification audit: The decisive step

During the certification audit, an external auditor checks whether your company meets the ISO 9001 requirements. This is the last step before receiving the certificate.

Our support: We accompany you through the entire audit process and are on hand to answer any questions or challenges you may have. Our aim is to make the audit as smooth as possible and ensure successful certification.

6. receipt of the certificate: Your seal of quality

After the successful audit, you will receive the ISO 9001 certificate, which is valid for three years and confirms that your company meets the highest quality standards.

What comes next? Regular internal audits and continuous improvements are crucial in order to maintain certification in the long term and to be successful in the recertification process.

Conclusion: Your partner for successful ISO 9001 certification

ISO 9001 certification requires careful planning and specialist knowledge. With our advice at your side, the process will be smooth and efficient. Contact us to find out more about our customized consulting services and make your certification a success. Get ahead and in touch with us – info@expertsinstitut.de



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Crossing Cultures in Audits and Inspections

Today the world, with its regulated industry, is strongly globalized. The cultural diversity of a company’s staff can be huge, reflecting different cultures from around the world. This is one reason why many would assume that the entire world can be talked to, related to, and understood quite readily. It is part of everyday work for many after all-or so we think.

In the area of audits and inspections, crossing cultures happens all the time. Different cultures bring different perspectives, which can influence how audits are perceived and conducted. Where supply chains are globalized, trans-national and trans-continental audits and inspections are mandatory and pretty much normal in many company and regulatory settings. Understanding the nuances of each culture involved is essential for effective communication and successful outcomes.

True Multiculturalism and Cultural Limits

This poses a problem though: we learn to communicate, read, and perceive in our birth culture. And even if a society is highly diverse, we are still product of a cultural framework that is discrete-in other words, that has boundaries. It is simply impossible for one person to really become multicultural-ourlifespan is just not large enough. You may be the child of a double or third culture set of parents, but true multiculturalism in a single individual is virtually impossible.

So as we are controlled by our birth culture, we do not learn how to properly navigate in foreign cultural contexts (and globalization does not do away with this at all). We may think we know what is going on around us when we engage people from other host cultures, but we really do not. Even in a seasoned friendship with someone from another country, there will still be a vast degree of ignorance in understanding the other person. We believe we know and understand. But we miss most of it in reality. We continue to filter everything we experience, see, hear and judge through what we believe is normal, and our frame of reference is our birth culture. And we cannot stop doing it because we are not even aware of it.

The Impact of Culture on Audits and Inspections

And now it gets interesting: This problem includes audit and inspection situations!
Good auditing is more than knowing compliance requirements, audit methodology, and a work experience of 100+ or even 1000+ audits.

Culture is so powerful that it controls everything we think, say and do. And what we expect of others. In an audit situation (also in GMP inspections), this routinely produces misunderstandings. And many of them are never corrected, simply because neither the auditor nor the auditee is aware of them.

From document reviews, an auditor may conclude that a company is falsifying records, when the truth is though that what the auditor saw has nothing to do with cheating at all.

An auditor may think the auditee is trying to avoid saying the truth about a given audit question or subject, but there is no intent of this in the conversation at all. But the auditor is blind to this.

As a result of examples like these, auditors will put their impressions into the report, in a coded form of course, but it will color all parts of the report and the perception of GMP deficiencies-even the judgment on severeness.

If an auditor is not aware of what is missed and where the personal perception of things is going astray, then such an auditor must improve. The objectiveness of the report will suffer, and the picture that is brought home is greatly inaccurate. We do a disservice to the auditee and to our own sending unit. And frankly, to ourselves…

This plays out even more drastically in audits of suppliers or service providers where no GMP or GxP quality system is available. Such cultural ignorance can make or break the business relationship altogether.

How can you improve?

  • Stop thinking that cultural differences are easy to figure out. You cannot guess them. You need extra training for this.
  • Understand that cultural differences have little to do with differing food preferences or how a business card must be presented.
  • Respect that standards-even GMP-can be lived effectively in different ways.
  • Open to the truth that you do not know everything best.

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